Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]
We have done a number of posts on the FDA’s activities with regard to assuring the safe use of benzodiazepines (here, here, and here, where we discuss issues regarding increased warnings and potential REMs, and even the specter of abuse-deterrent formulations being applied to benzodiazepines (here)). While no one knows where this will end up, […]
In my October 5, 2021 post (here), I discussed what appeared to be a significant dip in ANDA approval and tentative approval actions, as well as a decrease in the number of ANDA submissions. I mentioned that I did not have further insight as to the decline in these metrics but did mention that maybe […]
Tomorrow, FDA will issue a revised draft guidance on Hearing Aids and Personal Sound Amplification Products (PSAP) (here), and is also publishing a proposed rule for the over the counter (OTC) classification of hearing aids (HA) and PSAP (here) entitled “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids”. These are the prepublication […]
According to the FDA All Approval list, OGD reported 28 full approval actions and two (2) tentative approval actions thru 10AM ET on October 15, 2021 (here) for a total of 30 approval actions midway through the month. This is a more favorable figure than we reported for the midway point of September (here) where […]
Well, we have been seeing certain information on ANDA suitability petitions since FDARA passed, but only the information required by the Act. The FDA reports a separate list of petitions that have been filed, those that are pending, or those that have been acted upon. Unfortunately, according to the FDA page where the list resides […]
Overnight, FDA updated its metrics for August and also provided some critical metrics to end out FY 2021 (here). Let’s take a look at the August update first. OGD issued three (3) Refuse-to-Receive letters in August, which appears to be consistent with the numbers for the year (with the exception of 11 RTRs that were […]
In a prepublication Federal Register (FR) notice (here), the “Food and Drug Administration (FDA or Agency) is announcing the withdrawal of three guidance documents titled ‘Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),’ ‘Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health […]
Today, the FDA issued a third revision of a draft guidance titled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here). The Agency revised this guidance, which was previously revised in June 2016, in response to comments submitted to that document. The revised document describes how and […]
Well, September saw not only a low for this fiscal year (FY) of forty‑two total approval actions (both full (thirty‑nine) and tentative (three) approvals), but you have to go all the way back to February 2018 to find a lower number of total approval actions (thirty-seven). And, remember, that number was caused by the approval […]
